INDICATIONS
Venofer® (iron sucrose injection, USP) is an iron replacement product indicated for the treatment of
iron deficiency anemia in patients with chronic kidney disease (CKD)1:
Venofer® is contraindicated in patients with known hypersensitivity to Venofer®.

DOSAGE & ADMINISTRATION

Population

Dose

Administration

Adult patients

Hemodialysis Dependent - Chronic Kidney Disease (HDD-CKD)

100 mg slow IV injection or infusion

Administer Venofer 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a
maximum of 100 mL of 0.9% NaCI over a period of at least 15 minutes, per consecutive hemodialysis session. Venofer should be
administered early during the dialysis session. The usual treatment course of Venofer is 1000 mg.

Non-Dialysis Dependent - Chronic Kidney Disease (NDD-CKD)

200 mg slow IV injection or infusion*

Administer Venofer 200 mg undiluted as a slow intravenous injection over 2 to 5 minutes or as an infusion of 200 mg in a
maximum of 100 mL of 0.9% NaCI over a period of at least 15 minutes. Administer on 5 different occasions over 14 day period.

Peritoneal Dialysis Dependent - Chronic Kidney Disease (PDD-CKD)

300 mg or 400 mg IV infusion

Administer Venofer in 3 divided doses, given by slow intravenous infusion, within a 28 day period: 2 infusions each of 300 mg
over 1.5 hours 14 days apart followed by one 400 mg infusion over 2.5 hours 14 days later. Dilute Venofer in a maximum of 250 mL of 0.9% NaCI.

Pediatric patients

HDD-CKD, PDD-CKD or NDD-CKD

0.5mg/kg slow IV injection or infusion

The dosing for iron replacement treatment in pediatric patients with HDD-CKD has not been established. For iron maintenance treatment:
Administer Venofer at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every two weeks for 12 weeks given undiluted by slow intravenous
injection over 5 minutes or diluted in 25 mL of 0.9% NaCl and administered over 5 to 60 minutes.

The dosing for iron replacement treatment in pediatric patients with NDD-CKD or PDD-CKD has not been established.
For iron maintenance treatment: Administer Venofer at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every four
weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 25 mL of 0.9% NaCl
and administered over 5 to 60 minutes.

*There is limited experience with administration of an infusion of 500 mg of Venofer, diluted in a maximum
of 250 mL of 0.9% NaCl, over a period of 3.5 to 4 hours on Day 1 and Day 14.

CONTRAINDICATIONS
Venofer® is contraindicated in patients with known hypersensitivity to Venofer.

WARNINGS AND PRECAUTIONSSerious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal,
have been reported in patients receiving Venofer. Patients may present with shock, clinically significant hypotension, loss of
consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Venofer
immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Venofer administration for at least
30 minutes and until clinically stable following completion of the infusion. Only administer Venofer when personnel and
therapies are immediately available for the treatment of serious hypersensitivity reactions.
Most reactions associated with intravenous iron preparations occur within 30 minutes of the completion of the infusion.

Venofer may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer.
Hypotension following administration of Venofer may be related to rate of administration and/or total dose delivered.

Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis.
All adult and pediatric patients receiving Venofer require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit,
serum ferritin and transferrin saturation). Do not administer Venofer to patients with evidence of iron overload. Transferrin saturation (TSAT)
values increase rapidly after intravenous administration of iron sucrose; do not perform serum iron measurements for at least 48 hours after intravenous dosing.

Because adverse reactions from post-marketing experience are reported voluntarily from a population of uncertain size, it is not always possible to reliably
estimate their frequency or establish a causal relationship to drug exposure. In addition to potential serious hypersensitivity reactions, the following adverse
reactions have been identified during post-approval use of Venofer® (iron sucrose injection, USP): bronchospasm, dyspnea, convulsions, light-headedness, confusion,
angioedema, swelling of the joints, hyperhidrosis, bradycardia and chromaturia.

Symptoms associated with Venofer total dosage or infusing too rapidly included hypotension, dyspnea, headache, vomiting, nausea, dizziness, joint aches, paresthesia,
abdominal and muscle pain, edema and cardiovascular collapse. These adverse reactions have occurred up to 30 minutes after the administration of Venofer injection.
Reactions have occurred following the first dose or subsequent doses of Venofer. Slowing the infusion rate may alleviate symptoms.

Injection site discoloration has been reported following extravasation. Assure stable intravenous access to avoid extravasation.

PP-VE-US-0001 10/2016

To report adverse events, please contact American Regent at 1-800-734-9236.
You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.